Court File No. 3' FEDERAL COURT ease? ease SEP . 2015 JENA RUSSELL Umrm?? mm C) 13 mm - Tamara, ea ALEXION PHARMACEUTICALS INC. Applicant -md_ PATENTED NIEDICINE PRICES REVIEW BOARD and ATTORNEY GENERAL OF CANADA . Respondents APPLICATION UNDER section 18.1 and 18.2 of the Federal Coms Act, RSC. 1985, c. 7 (the ?Federal Courts Act?), and Part of the Federal Court Rules, 1998, as amended NOTICE OF APPLICATION UNDER SECTIONS 18(1)(a) and 18(1)(b) OF THE FEDEIML COURTSACT J. A LEGAL PROCEEDING HAS BEEN COMMENCED AGAINST YOU by the Applicant. The relief claimed against you is set out in the following pages. THIS APPLICATION will be heard by the Court at a time and place to be ?xed by the Judicial Administrator. Unless the Court orders otherwise, the place of the hearing Will be as requested IF YOU WISH TO OPPOSE THIS APPLICATION, to receive notice of any step in the Application or to be served with any documents in the application, you or a solicitor acting for you must prepare a notice of appearance in FORM 305 prescribed by the Federal Courts Rules and serve it on the Applicant? solicitor, WITHIN 10 DAYS after being served with this Notice of Application Copies of the Federal Court Rules, information concerning the local o?ces of the Court and other necessary information may be obtained on request to the Administrator of this Court at Ottawa (613-992?423 8) or any local Of?ce. - IF YOU FAIL TO OPPOSE THIS APPLICATION, JUDGMENT MAY BE GIVEN AGAINST YOU IN YOUR ABSENCE AND WITHOUT FURTHER NOTICE TO YOU. tans RUSSELL O?l??i September 11, 2015 Issued by: I mam mg ?mm - O?icer) Address of local of?ce: 180 Queen Street West, Suite 200 Toronto, ON MSV 3L6 To: The Administrator of this Honourable Court Federal Court 180 Queen Street West, Suite 200 Toronto, ON MSV 3L6 And To: Patented Medicine Prices Review Board - The Secretary of the Patented Medicine Prices Review Boar 333 Iauri'er Avenue West, Suite 1400 Ottawa, ON KIP 1C1 And To: Attorney General Of Canada Attention: Director, Ontario Regional Of?ce Department of Justice (Toronto) 1 0 Street west, Suite 3400 - Box 36, Exchange Tower Toronto, ON MSX 1K6 APPLICATION NATURE OF APPLICATION This is an Application under sections 18(1)(a) and 18(1)(b) of the Federal Courts Act. The Applicant, Alexion Pharmaceuticals Inc. (?Alexion?), seeks a declaratory judgment against the Attorney General of Canada and a writ of prohibition against the Patented Medicine Prices Review Board (the ??Board?). ALEXION MAKES APPLICATION FOR ORDERS: Lt.) Declaring that sections 83 through 86 of the Patent Act RS. C. 1985, 0. P4, as amended (the ?Patent Act?), and the words ?in any proceeding under s. 83? in section 87(1) (the ?impugned provisions?) are ultra vires the Parliament of Canada in that the price regulation scheme created by the impugned provisions exceeds the powers granted to Parliament under s. 91(22), or other federal power, of the Constitution Act, 1867 and improperly intrudes into provincial jurisdiction over property and civil rights in the province under 8. 92(13) of the Constitution Act, I 8 6 7; That the Board be prohibited from proceeding with a hearing under s. 83 of the Patent Act, or making any order concerning the price at which Alexion is selling or has sold the medicine Soliris in any market in Canada. Such further or other relief as the Applicant requests and the Honourable Court deems just to grant. THE GROUNDS FOR THE APPLICATION ARE: 1. Alexion is a Delaware company located in Cheshire, Connecticut. It markets in Canada a patented medicine known as Soliris. 2. On January 20, 2015, the Board issued a Notice of Hearing notifying Alex-ion that the Board would ?determine whether, under section 83 and 85 of the Patent [Alexion] is selling or has sold. . .Soliris in any market in Canada at a price that, in the Board?s opinion, is or was excessive and if so, what order, if any, should be made.? 3. The Notice of Hearing further states: B. POWER OF BOARD WITH RESPECT TO EXCESSIVE PRICES 2. In the event that the Board ?nds that the Respondent (Alexion) is selling Soliris in any market in Canada at a price that, in the Board?s opinion, is excessive, the Board may, by order, direct the Respondent to cause the maximum price at which the Respondent sells Soliris in that market to be reduced to such level as the Board considers not to be excessive and as is speci?ed in the order. 3. In addition, in the event that the Board ?nds that the Respondent has, while a patentee, sold Soliris in any market in Canada at a price that, in the Board?s opinion was excessive, the Board may, by order, direct the Respondent to do any one or more of the following things as will, in the Board?s opinion, offset the amount of the excess revenue determined by it to have been derived by the Respondent from the sale of Soliris: reduce the price at which the Respondent sells the medicine in any market in Canada, to such extent and for such period as is speci?ed in the order; reduce the price at which the Respondent sells one other medicine to which a patented invention of the Respondent pertains in any market in Canada, to such extent and for such periodas is speci?ed in the order; (0) pay to Her Majesty in right of Canada an amount speci?ed in the order. 4. Any other remedies Board Staff may seek and the Board may permit. The price of Soliris in Canada has neither increased since it was ?rst introduced on the Canadian market in 2009, nor decreased in the countries where the product is sold outside Canada. In 2010 and 2011, the Board explicitly acknowledged that the introductory price of Soliris was not excessive based on international pricing of the product. The Board?s allegations of excessive pricing between 2012 and 2014 are not based on price increases in Canada or price decreases outside Canada but, rather, on exchange rate ?uctuations in the value of Canadian currency due to factors that the Board acknowledges are outside Alexion's control. The Board is thus seeking to use its alleged price control powers to con?scate a signi?cant portion of Alexion's revenues based upon international market forces over which Alexion has no control. In public documents, the Board describes its mandate as ?protect[ing] consumers? and its ?mission? as ?c0ntribut[ing] to Canadian health care by ensuring that prices of patented medicines are not excessive.? The Board?s stated objectives of protecting consumers and promoting health care cannot be grounded in the federal power to control patents of invention and discovery under 3. 91(22) of the Constitution Act, 1867 or other federal power under that Act. 8. The federal price regulation scheme created by the impugned provisions intrudes on provincial jurisdiction over property and civil rights under 8. 91(13) of the Constitution Act, I 86 7. The scheme is invalid and, given the extent of the intrusion into provincial jurisdiction, cannot be suf?ciently integrated within the Patent Act. 9. Price controls by the federal government are permitted only in national emergencies that do not exist in relation to the price of Soliris or other patented medicines. 10. Such further and other grounds as counsel may argue and this Honourable Court hear. I THE APPLICATION WILL BE SUPPORTED BY THE FOLLOWING MATERIAL: l. The Applicant?s Legislative History Brief; 2. Af?davits of Jonathan D. Putnam and Lionel Bently to be ?led; and 3. Such further and other material as counsel may adduce and this Honourable Court admit. Date: September 11 2015 GOWLING LAFLEUR HENDERSON LLP Barristers Solicitors 1 First Canadian Place, 100 King Street West, Suite 1600 Toronto ON MSX 1G5 Tel: 416-862?7525 Fax: 416-862-7661 Malcolm Ruby Tel: 416-862-4314 Fax: 41 6-862-7 661 malcolrn.ruby@gowlings.com David T. Woodfield Tel: 416-862-4313 Fax: 416-862-7661 Lawyers for the Applicant Ra's-4w" Court File No. ELLEHON PHARMACEUTICALS INC. - and - PATENTED NEEDICINE PRICES REVIEW BOARD et al Applicant Respondents FEDERAL COURT PROCEEDIN COMMENCED AT TORONTO . NOTICE OF APPLICATION Ex GOWLING LAFLEUR HENDERSON LLP Barristers Solicitors g7 1 First Canadian Place 100 King Street West, Suite 1600 Toronto ON MSX 1G5 2 2m that the above document is a true Copy of 1 a 21115 the origins} issued out of I ?ler-i in the Court on the H. in .3.- Tel: 416-862-7525 Fax: 416?862-7661 I day of . Dated this Malcolm Ruby Tel: 416-862-4314 Fax: 416-862-7661 malcolm.ruby@gowlings.com David T. Woodficld (#4122911) Tel: 416?862-4313 Fax: 416-862-7661 Lawyers for the Applicant